NCT04774731

Brief Summary

The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

February 24, 2021

Last Update Submit

September 19, 2022

Conditions

Hemodialysis

Keywords

whole body vibrationhemodialysisgait function

Outcome Measures

Primary Outcomes (1)

  • Change in the timed up and go test

    12 weeks after starting intervention

Secondary Outcomes (2)

  • Change in the one-leg standing test

    12 weeks after starting intervention

  • Change in the 30-second chair-stand test

    12 weeks after starting intervention

Study Arms (2)

Whole Body Vibration

EXPERIMENTAL
Other: Whole Body Vibration

Control

NO INTERVENTION

Interventions

Whole Body VibrationOTHER

Receiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session.

Whole Body Vibration

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Undergoing maintenance hemodialysis three times a week .

You may not qualify if:

  • Having difficulty in walking by oneself.
  • Having difficulty in receiving whole body vibration training because of cognitive impairment.
  • History of fracture of lower limb within 1 year.
  • History of total hip arthroplasty.
  • Unsuitable for participant in the trial by an attending physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 5650871, Japan

Location

Related Publications (1)

  • Asahina Y, Sakaguchi Y, Kajimoto S, Hattori K, Oka T, Kaimori JY, Kashihara N, Isaka Y. A Randomized Controlled Trial of Whole-Body Vibration on Gait Ability and Balance among Older Hemodialysis Patients. Clin J Am Soc Nephrol. 2023 Jan 1;18(1):84-90. doi: 10.2215/CJN.0000000000000018.

    PMID: 36719160DERIVED

Study Officials

  • Yusuke Sakaguchi, MD, PhD

    Department of Nephrology, Osaka University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

April 1, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

JP(1)